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MDCO Progresses with Fibrocaps - Analyst Blog

The Medicines Company
(
MDCO
) received encouraging news when the European Medicines Agency
(EMA) accepted its marketing authorization application (MAA) for
pipeline candidate Fibrocaps, for review.

Fibrocaps, a dry powder topical formulation of fibrinogen and
thrombin, is developed to stop bleeding during surgery.

The MAA was submitted on the basis of positive results from a
phase III study, FINISH, wherein Fibrocaps was evaluated as an
adjunct to hemostasis in patients undergoing surgical procedures.
The study used Fibrocaps to control mild or moderate bleeding
when conventional surgical techniques were ineffective.

Meanwhile, The Medicines Co. plans to submit its biologics
license application (BLA) for Fibrocaps to the United States Food
and Drug Administration (FDA) in the first quarter of 2014.

Additionally, the company also plans to submit a 510(k)
application with the FDA for the approval of a complementary
spray delivery device meant for the accurate application of
Fibrocaps. This device was recently granted a CE mark in
Europe.

We note that Fibrocaps was added to The Medicines Co.'s
pipeline when it acquired the Dutch company, ProFibrix B.V., in
Aug 2013. The company acquired ProFibrix following the
announcement of positive phase III data on Fibrocaps.

We believe, Fibrocaps, if approved, may have an advantage over
the existing products, as it can be used at room temperature and
does not require thawing before use. The Medicines Co. believes
that Fibrocaps peak sales could exceed $300 million provided it
gains approval in major markets.

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